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NDC 00363-0159-15 Headache Relief 250; 250; 65 mg/1; mg/1; mg/1 Details

Headache Relief 250; 250; 65 mg/1; mg/1; mg/1

Headache Relief is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is ACETAMINOPHEN; ASPIRIN; CAFFEINE.

Product Information

NDC	00363-0159
Product ID	0363-0159_5c70c226-5c04-406c-9d6a-f9fe090afd3b
Associated GPIs	64990003200350
GCN Sequence Number	016524
GCN Sequence Number Description	dextromethorphan HBr LIQUID 15 MG/5 ML ORAL
HIC3	H6C
HIC3 Description	ANTITUSSIVES, NON-OPIOID
GCN	17748
HICL Sequence Number	001925
HICL Sequence Number Description	DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Headache Relief
Proprietary Name Suffix	Extra Strength
Non-Proprietary Name	Acetaminophen, Aspirin, Caffeine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	250; 250; 65
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; ASPIRIN; CAFFEINE
Labeler Name	Walgreen Company
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [E
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	n/a

Package

Package Images

NDC 00363-0159-15 (00363015915)

Pricing Information	N/A
NDC Package Code	0363-0159-15
Billing NDC	00363015915
Package	1 BOTTLE, PLASTIC in 1 CARTON (0363-0159-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date	1992-11-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fbdd8197-60f3-4b48-9f36-809beed873c1 Details

Active ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:
- toothache
- arthritis
- a cold
- headache
- muscular aches
- premenstrual and menstrual cramps

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

hives
shock
facial swelling
asthma (wheezing)

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
3 or more alcoholic drinks every day while using this product
with other drugs containing acetaminophen

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

you have liver disease
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis
taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody of black stools
- vomit blood
- have stomach pain that does not get better
ringing in the ears or a loss of hearing occurs
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
redness or swelling is present
new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed
drink a full glass of water with each dose
adults and children 12 years and over
- take 2 tablets every 6 hours
- do not take more than 8 tablets in 24 hours
children under 12 years: ask a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to Excedrin® Extra

Strength active ingredients††

NDC 0363-0159-15

Headache Relief

ACETAMINOPHEN / ASPIRIN (NSAID) / PAIN RELIEVER

CAFFEINE / PAIN RELIEVER AID

EXTRA STRENGTH

TABLETS

50 ANALGESIC

TABLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or distributed by

Novartis AG, owner of the registered trademark

Excedrin® Extra Strength.

50844 ORG041815915

Walgreens 44-159B

INGREDIENTS AND APPEARANCE

HEADACHE RELIEF EXTRA STRENGTH

acetaminophen, aspirin, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0159
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;159
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0159-15	1 in 1 CARTON	11/17/1992	04/28/2023
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:0363-0159-12	1 in 1 CARTON	11/17/1992	04/28/2023
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:0363-0159-29	1 in 1 CARTON	11/17/1992	07/28/2017
3		150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	11/17/1992	04/28/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0363-0159)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(0363-0159)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0159)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0363-0159)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(0363-0159)

Revised: 10/2022

Document Id: 5c70c226-5c04-406c-9d6a-f9fe090afd3b

Set id: fbdd8197-60f3-4b48-9f36-809beed873c1

Version: 15

Effective Time: 20221012